Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct

June 27, 2023By Véronique Li, Senior Medical Device Regulation Expert & Anne K. Walsh

Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here).  FDA now seeks comments on this very program to support its continued collection of information as required under the Paperwork Reduction Act.  On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH.  Specifically, FDA invited comments on:

  1. Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
  2. The accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
  3. Ways to enhance the quality, utility, and clarity of the information to be collected; and
  4. Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Any comments to the public notice must be submitted by August 11, 2023.

FDA’s Collection of Information

As noted in our prior blog post, FDA requests that the following information be submitted with each complaint to help the Agency assess an allegation:

  • Name of the company;
  • Address and telephone number of the company;
  • Name of the device and model;
  • Lot/serial/part numbers;
  • Unique Device Identifier (UDI); and/or
  • Recall numbers.

FDA also requests a “detailed description of the allegation with any available supporting documentation.”  In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission.  We have seen companies submit screenshots of social media sites making misleading promotional claims, pictures of violative product labeling, and evidence of damaged or uncalibrated manufacturing equipment.

Supporting information is critical to illustrate the specific points of regulatory misconduct.  Companies typically already have this information collected internally, well before contemplating a voluntary submission to FDA, so it is not overly burdensome to collect the information.  More importantly, the proposed collection is necessary for FDA to identify the offending manufacturer and confirm its regulatory misconduct.

Estimate of Burden

In the public notice, FDA estimates that it receives 2,500 voluntary submissions a year, and that it takes FDA an average of 15 minutes to respond to each submission.  This statistic is quite disheartening.  Companies labor over the initial decision of whether to submit an allegation to FDA, and even after deciding to take action, dedicate significant resources to prepare a thoughtful submission, with supporting documentation, for FDA consideration.  FDA’s template responses appear to be generated automatically to simply acknowledge receipt and assign a document number (hardly a 15 minute endeavor).

We understand that 15 minutes is simply an estimate of the average time it takes FDA to review each submission, but it suggests nothing more than a cursory glance, if at all, on those submissions that allege, with supporting documentation, very serious offenses akin to those that have been cited in warning letters and 483s.  Further, it is hard to reconcile the 15 minute per response estimate with FDA’s recommendation to check on the status six months after an allegation has been submitted to FDA.

We can only conclude that the estimate of burden is grossly under-representative of efforts FDA should be taking to consider the information submitted to FDA under this program.

Ways to Enhance Information

There is little transparency in how FDA prioritizes and reviews the information submitted to it.  We understand that FDA prioritizes review based on the level of potential risks, as assessed by the allegation type and completeness of information.  FDA does not define, however, when information submitted is deemed to be “complete.”

To provide transparency to industry, and to assist FDA prioritize and conduct its review, FDA should bolster its website to include specific examples of appropriate information to include in voluntary submissions.  FDA could present this information in a Frequently Asked Questions (FAQ) section, like it uses on other webpages describing its programs.  Not only would this streamline the collection process, but it would enhance the quality, utility, and clarity of the information that is submitted to FDA to support allegations of misconduct.

Companies may decide to hold-off on private litigation against a non-compliant competitor to allow FDA to first address areas of public health concern.  Without any transparency on the process, however, companies do not know whether FDA has taken action, intends to take action, or does not deem the allegation meritorious.  Disclosure of this information, even in a redacted format, would further FDA’s public health mission and keep industry aware of, and compliant with, areas of urgent concern.  Under the current process, FDA recommends waiting six months after submitting the allegation(s) to submit a Freedom of Information Act (FOIA) request for related records.  As we discussed in our prior blog post, there needs to be a better way to understand the outcome of FDA’s review.  Those who submit an allegation should be notified directly, not asked to go through a laborious (and sometimes unfruitful) process of submitting a FOIA request to only receive redacted pages.

Ways to Minimize Burden of Information Collection

FDA currently accepts voluntary submission of allegations of regulatory misconduct through electronic form, email, or regular mail. There are drawbacks to the current communication channels: 1.) The electronic form does not allow for attachments; it requests that you separately email any attachments; 2.) We have usually received a same day acknowledgment to our email submission and no substantive follow-up; and 3.) It is not known how long it would take FDA to respond to allegations via regular mail.

For these shortcomings, we suggest the adoption of the CDRH Customer Collaboration Portal in its efforts to receive, track, and provide updates on the status of any voluntarily submitted allegation(s). In our experience, the portal has the ability to accept supporting documentation in the form of PDF attachments, no larger than 1 GB. That would create a central location for all documents and information regarding the allegation. Unlike the current state, which is to submit a FOIA request and receive redacted information six months (at the earliest), the CDRH Customer Collaboration Portal would allow a submitter to track FDA’s progress. We hope the status is more than just an “Under Review” label. Finally, a submitter would receive the potential benefit of more tangible information.

In conclusion, there is merit in FDA’s collection of information involving allegations of regulatory misconduct, but it can be improved. We recommend companies submit comments to FDA on the areas FDA can change to improve the user (submitter) experience and provide greater transparency on the outcomes of the information collected. Without improvements, companies may decide that this program is not a useful pathway for addressing regulatory misconduct, and the quality of information FDA receives will only decline.